{"id":3850,"date":"2022-01-12T09:46:43","date_gmt":"2022-01-12T09:46:43","guid":{"rendered":"https:\/\/topdiag.com\/?p=3850"},"modified":"2022-02-07T13:53:36","modified_gmt":"2022-02-07T13:53:36","slug":"noutati-in-portofoliul-de-produse-top-diagnostics-pentru-diagnosticul-si-monitorizarea-covid-19","status":"publish","type":"post","link":"https:\/\/topdiag.com\/ro\/2022\/01\/12\/noutati-in-portofoliul-de-produse-top-diagnostics-pentru-diagnosticul-si-monitorizarea-covid-19\/","title":{"rendered":"Nout\u0103\u021bi \u00een portofoliul de produse Top Diagnostics privind diagnosticul \u0219i monitorizarea COVID-19"},"content":{"rendered":"<blockquote><p><strong>Noile variante emergente de SARS-CoV-2 reprezint\u0103 o preocupare major\u0103 la nivel mondial. Aceste variante pot prezenta o transmisibilitate crescut\u0103 \u0219i pot evita chiar r\u0103spunsul imun, reprezent\u00e2nd prin urmare o amenin\u021bare suplimentar\u0103 \u00een \u00eencercarea de a controla r\u0103sp\u00e2ndirea virusului \u0219i pentru succesul strategiilor de vaccinare. Identificarea acestor variante ajut\u0103 la urm\u0103rirea r\u0103sp\u00e2ndirii lor \u0219i permite supravegherea epidemiologic\u0103.<\/strong><\/p><\/blockquote>\n<p>\u00cen acest context, Top Diagnostics aduce comunit\u0103\u021bii medicale din Rom\u00e2nia produse inovatoare pentru diagnosticul \u0219i monitorizarea COVID-19.<\/p>\n<p><span style=\"color: #3366ff;\"><strong>1.TESTARE RAPID\u0102 PENTRU DETEC\u021aIA ANTIGENULUI COVID-19<\/strong><\/span><\/p>\n<p><strong>1.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<a href=\"https:\/\/topdiag.com\/ro\/product\/ng-biotech-ninonasal-sars-cov-2-antigen\/\">NG Biotech Ninonasal\u00ae SARS-CoV-2 ANTIGEN<\/a><\/strong><\/p>\n<p>Testul identific\u0103 prezen\u021ba antigenului SARS-CoV-2 \u00een 15 minute, av\u00e2nd o specificitate de 99% \u0219i o sensibilitate de 98%.Ninonasal\u00ae detecteaz\u0103 urm\u0103toarele variante ale virusului SARS-CoV-2: \u201eAlpha\u201d, \u201cBeta\u201d, \u201cGamma\u201d, \u201cDelta\u201d, \u201cEpsilon\u201d, \u201cMu\u201d, \u201cLambda\u201d, \u201cIota\u201d, \u201cKappa\u201d, \u201cEta\u201d \u0219i \u201cOmicron\u201d.<\/p>\n<p>Produc\u0103tor: NG Biotech SAS, Fran\u021ba<\/p>\n<p><strong>1.2\u00a0 \u00a0 \u00a0 \u00a0\u00a0<a href=\"https:\/\/topdiag.com\/ro\/product\/schebo-%e2%80%a2-sars-cov-2-quick-antigen\/\"> ScheBo\u00ae \u2022 SARS-CoV-2 Quick\u2122 ANTIGEN<\/a><\/strong><\/p>\n<p>Test rapid imunocromatografic cu fluorescen\u021b\u0103 pentru detec\u021bia calitativ\u0103 a antigenului SARS-CoV-2. Testul identific\u0103 prezen\u021ba antigenului SARS-CoV-2 \u00een 15 minute, av\u00e2nd o specificitate de 98.9% \u0219i o sensibilitate de 97.3%.<\/p>\n<p>Produc\u0103tor: ScheBo\u00ae \u2022 Biotech AG, Germania<\/p>\n<p><strong>1.3\u00a0 \u00a0 \u00a0 \u00a0\u00a0<a href=\"https:\/\/topdiag.com\/ro\/product\/maripoc-covid-19\/\"> mariPOC\u00ae Quick+ Flu<\/a><\/strong><\/p>\n<p>Test imunologic calitativ pentru diagnosticul infec\u021biilor respiratorii virale (metoda imunologic\u0103 tip sandwich cu detec\u021bie fluorescent\u0103), simultan, \u00een 20 de minute, a antigenului SARS-CoV-2, a virusului gripal A, a virusului gripal B \u0219i a virusului sinci\u021bial respirator uman, pentru diagnosticul infec\u021biilor respiratorii virale.<\/p>\n<p>Sensibilitate: 100%; Specificitate: 100%<\/p>\n<p>Produc\u0103tor: ArcDia International Oy, Finlanda<\/p>\n<p>Compatibil cu sistemul automat de imunologie <a href=\"https:\/\/topdiag.com\/ro\/product\/arcdia-maripoc\/\">mariPOC\u00ae<\/a><\/p>\n<p><strong>1.4\u00a0 \u00a0 \u00a0 \u00a0 \u00a0<a href=\"https:\/\/topdiag.com\/ro\/product\/maripoc-covid-19\/\">mariPOC\u00ae SARS-CoV-2<\/a><\/strong><\/p>\n<p>Test imunologic (metoda imunologic\u0103 tip sandwich cu detec\u021bie fluorescent\u0103) pentru detec\u021bia calitativ\u0103 a antigenului SARS-CoV-2.<\/p>\n<p>Sensibilitate: 92.3%; Specificitate: 100%<\/p>\n<p>Produc\u0103tor: ArcDia International Oy, Finlanda<\/p>\n<p>Compatibil cu sistemul automat de imunologie <a href=\"https:\/\/topdiag.com\/ro\/product\/arcdia-maripoc\/\">mariPOC\u00ae<\/a><\/p>\n<blockquote><p><strong>Testele rapide pentru detec\u021bia antigenului SARS-CoV-2 din portofoliul Top Diagnostics sunt incluse \u00een lista testelor recunoscute de statele membre UE pentru COVID-19.<\/strong><\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #3366ff;\"><strong>2. TESTARE ANTICORPI ANTI SARS-CoV-2<\/strong><\/span><\/p>\n<p><strong>2.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/topdiag.com\/ro\/product\/testnow-covid-19-nab\/\">TestNOW\u00ae COVID-19 NAb<\/a><\/strong><\/p>\n<p>Test imunocromatografic rapid pentru detec\u021bia cantitativ\u0103 a anticorpilor neutralizan\u021bi circulan\u021bi (NAb) anti SARS-CoV-2 (titru NAb), ce blocheaz\u0103 interac\u021biunea dintre domeniul de legare la receptor (RBD) al proteinei virale Spike (S) cu receptorul de suprafa\u021b\u0103 celular\u0103 al enzimei de conversie a angiotensinei 2 (ACE2), care func\u021bioneaz\u0103 ca receptor de suprafa\u021b\u0103 al celulelor umane, \u00een vederea evalu\u0103rii statusului de protec\u021bie imun\u0103.<\/p>\n<p>Coronavirusul Sindromului Acut Respirator Sever 2 (SARS-CoV-2 sau 2019-nCoV) este constituit dintr-o singur\u0103 molecul\u0103 de ARN \u0219i 4 proteine majore: glicoproteina spike (S), proteina E de \u00eenveli\u0219 (E), proteina M de membran\u0103 (M) \u0219i proteina N a nucleocapsidei (N). Subunitatea S1 a glicoproteinei spike (S) con\u021bine domeniul de legare la receptor (RBD) care este responsabil pentru recunoa\u0219terea receptorului de suprafa\u021b\u0103 celular\u0103, enzima de conversie a angiotensinei 2 (ACE2). S-a descoperit ca RBD al proteinei S interac\u021bioneaz\u0103 puternic cu receptorul uman ACE2, duc\u00e2nd la endocitoza profund\u0103 \u00een celulele gazd\u0103 ale pl\u0103m\u00e2nului \u0219i la replicarea viral\u0103.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-3856\" src=\"https:\/\/topdiag.com\/content\/uploads\/2022\/01\/SAR-CoV-2.png\" alt=\"\" width=\"444\" height=\"213\" srcset=\"https:\/\/topdiag.com\/content\/uploads\/2022\/01\/SAR-CoV-2.png 444w, https:\/\/topdiag.com\/content\/uploads\/2022\/01\/SAR-CoV-2-300x144.png 300w, https:\/\/topdiag.com\/content\/uploads\/2022\/01\/SAR-CoV-2-250x120.png 250w\" sizes=\"auto, (max-width: 444px) 100vw, 444px\" \/><\/p>\n<p>Infec\u021bia cu SARS-CoV-2 sau vaccinarea anti COVID-19 ini\u021biaz\u0103 un r\u0103spuns imun, care include producerea de anticorpi \u00een s\u00e2nge. Anticorpii secreta\u021bi ofer\u0103 protec\u021bie \u00eempotriva viitoarelor infec\u021bii virale, deoarece r\u0103m\u00e2n \u00een sistemul circulator luni sau ani \u0219i se vor lega rapid \u0219i puternic de agentul patogen pentru a bloca infiltrarea \u0219i replicarea celular\u0103. Aceste subgrupe de anticorpi de tip IgG sunt denumi\u021bi <em>anticorpi de neutralizare<\/em> (NAb). Studiile clinice au ar\u0103tat c\u0103 anticorpii de tip IgG anti RBD se coreleaz\u0103 cel mai bine cu activitatea de neutralizare a virusului \u0219i severitatea bolii.<\/p>\n<ul>\n<li>Tip de prob\u0103: s\u00e2nge total, ser, plasm\u0103, s\u00e2nge capilar<\/li>\n<li>Rezultate disponibile \u00een doar 15 minute<\/li>\n<li>Testul necesit\u0103 doar 10 \u00b5l de s\u00e2nge capilar<\/li>\n<li>Corela\u021bie excelent\u0103 cu \u201eFirst WHO International Standard for anti-SARS-CoV-2 Immunoglobulins\u201d (NIBSC Code: 20\/136)<sup>1,2,3<\/sup>, cu un coeficient de corela\u021bie R<sup>2<\/sup> = 0.99 <img loading=\"lazy\" decoding=\"async\" class=\" wp-image-3873 alignright\" src=\"https:\/\/topdiag.com\/content\/uploads\/2022\/01\/WHO-1.png\" alt=\"\" width=\"213\" height=\"304\" \/><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Rezultate \u00een unit\u0103\u021bi de raportare <strong>standardizate<\/strong> pentru anticorpii de legare BAU\/ml (BAU=Binding Antibody Unit) conform recomand\u0103rilor OMS <img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3872 alignright\" src=\"https:\/\/topdiag.com\/content\/uploads\/2022\/01\/1.png\" alt=\"\" width=\"196\" height=\"345\" \/><\/li>\n<li>Limita de detec\u021bie (LOD): 25-50 BAU\/ml (\u00een func\u021bie de lot)<\/li>\n<li>Sensibilitate: 99.17%; Specificitate: 98.67%<\/li>\n<li>Marc\u0103 CE-IVD<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Produc\u0103tor: Affimedix Inc., USA<\/p>\n<p>Compatibil cu cititorul automat <a href=\"https:\/\/topdiag.com\/ro\/product\/testnow-covid-19-nab\/\">RapiRead CUBE<\/a> dedicat testului TestNOW\u00ae COVID-19.<\/p>\n<p>&nbsp;<\/p>\n<p>Referin\u021be:<\/p>\n<ol>\n<li>Standardization of vaccines for coronavirus disease (COVID-19); 29 March 2021 <a href=\"https:\/\/www.who.int\/news-room\/feature-stories\/detail\/standardization-of-vaccines-for-coronavirus-disease-covid-19\">https:\/\/www.who.int\/news-room\/feature-stories\/detail\/standardization-of-vaccines-for-coronavirus-disease-covid-19<\/a><\/li>\n<li><a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(21)00527-4\/fulltext\">https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(21)00527-4\/fulltext<\/a><\/li>\n<li><a href=\"https:\/\/www.nibsc.org\/documents\/ifu\/20-136.pdf\">https:\/\/www.nibsc.org\/documents\/ifu\/20-136.pdf<\/a><\/li>\n<\/ol>\n<p><strong>2.2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/topdiag.com\/ro\/product\/schebo-%e2%80%a2-sars-cov-2-quick-igm-igg\/\">ScheBo\u00ae \u2022 SARS-CoV-2 Quick\u2122 (IgM\/IgG)<\/a><\/strong><\/p>\n<p>Test rapid imunocromatografic pentru detec\u021bia calitativ\u0103 \u0219i diferen\u021bierea anticorpilor anti SARS-CoV-2 de tip IgM \u0219i IgG. Testul identific\u0103 prezen\u021ba anticorpilor anti SARS-CoV-2 de tip IgM \u0219i IgG, anti-nucleocapsid\u0103 \u0219i anti-spike, \u00een 15 minute, cu urm\u0103toarele caracteristici de performan\u021b\u0103:<\/p>\n<p>SARS-CoV-2 IgM &#8211; Sensibilitate: 97.5% \u0219i Specificitate: 99.5 %<\/p>\n<p>SARS-CoV-2 IgG &#8211; Sensibilitate: 97.5% \u0219i Specificitate: 100%<\/p>\n<p>Marc\u0103 CE-IVD.<\/p>\n<p>Produc\u0103tor: ScheBo\u00ae \u2022 Biotech AG, Germania<\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #3366ff;\"><strong>3. DETEC\u021aIE RT-PCR COVID19<\/strong><\/span><\/p>\n<p><strong>3.1\u00a0 \u00a0 \u00a0 \u00a0 \u00a0<a href=\"https:\/\/topdiag.com\/ro\/product\/fluorotype-sars-cov-2-varid-q\/\">FluoroType\u00ae SARS-CoV-2 varID Q<\/a><\/strong> este un test PCR multiplex pentru detec\u021bia \u0219i cuantificarea SARS-CoV-2 \u0219i identificarea simultan\u0103 a patru muta\u021bii diferite ale genei S ale virusului SARS-CoV-2.<\/p>\n<ul>\n<li><strong>Del69-70 <\/strong>&#8211; specific\u0103 variantelor Alpha \u0219i Omicron<\/li>\n<li><strong>N501Y <\/strong>&#8211; specific\u0103 variantelor Alpha, Beta, Gamma \u0219i Omicron<\/li>\n<li><strong>E484K <\/strong>&#8211; specific\u0103 variantelor Beta \u0219i Gamma<\/li>\n<li><strong>D80A <\/strong>&#8211; specific\u0103 variantei Beta<\/li>\n<\/ul>\n<p>Dou\u0103 gene independente ale genomului SARS-CoV-2 sunt vizate, oferind astfel o identificare sigur\u0103 a SARS-CoV-2, iar evaluarea \u00eenc\u0103rc\u0103turii virale conform NIBSC First WHO International Standard pentru ARN-ul SARS-CoV-2 (\u00een UI\/ml) ajut\u0103 la monitorizarea progresiei bolii.<\/p>\n<p><strong>3.2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/topdiag.com\/ro\/product\/fluorotype-sars-cov-2-evo\/\">FluoroType\u00ae SARS-CoV-2 evo<\/a><\/strong> este un test real-time PCR RUO pentru detec\u021bia calitativ\u0103 a noului coronavirus SARS-CoV-2 (gena RdRp) \u0219i diferen\u021bierea muta\u021biilor:<\/p>\n<ul>\n<li><strong>K417N <\/strong>&#8211; specific\u0103 variantelor Beta, Delta plus \u0219i Omicron<\/li>\n<li><strong>K417T <\/strong>&#8211; specific\u0103 variantei Gamma<\/li>\n<li><strong>E484Q <\/strong>&#8211; specific\u0103 variantei Kappa<\/li>\n<li><strong>L452E<\/strong><\/li>\n<li><strong>P681R <\/strong>&#8211; specific\u0103 variantelor Delta, Delta plus \u0219i Kappa<\/li>\n<\/ul>\n<p>Ambele kituri sunt compatibile cu urmatoarele platforme RT-PCR:<\/p>\n<ul>\n<li><a href=\"https:\/\/topdiag.com\/ro\/product\/hain-lifescience-fluorocycler-xt\/\">FluoroCycler\u00ae XT<\/a><\/li>\n<li>CFX96\u2122<\/li>\n<li>Rotor-Gene Q<\/li>\n<\/ul>\n<p>Produc\u0103tor: Hain Lifescience GmbH, Germania<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Noile variante emergente de SARS-CoV-2 reprezint\u0103 o preocupare major\u0103 la nivel mondial. Aceste variante pot prezenta o transmisibilitate crescut\u0103 \u0219i pot evita chiar r\u0103spunsul imun, reprezent\u00e2nd prin urmare o amenin\u021bare suplimentar\u0103 \u00een \u00eencercarea de a controla r\u0103sp\u00e2ndirea virusului \u0219i pentru succesul strategiilor de vaccinare. Identificarea acestor variante ajut\u0103 la urm\u0103rirea r\u0103sp\u00e2ndirii lor \u0219i permite supravegherea [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3018,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2,4],"tags":[],"class_list":["post-3850","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-press-releases"],"_links":{"self":[{"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/posts\/3850","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/comments?post=3850"}],"version-history":[{"count":30,"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/posts\/3850\/revisions"}],"predecessor-version":[{"id":3960,"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/posts\/3850\/revisions\/3960"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/media\/3018"}],"wp:attachment":[{"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/media?parent=3850"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/categories?post=3850"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/topdiag.com\/ro\/wp-json\/wp\/v2\/tags?post=3850"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}